CN113143881B - Empty capsule capable of being filled with aqueous liquid medicinal preparation - Google Patents
Empty capsule capable of being filled with aqueous liquid medicinal preparation Download PDFInfo
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- CN113143881B CN113143881B CN202110265936.7A CN202110265936A CN113143881B CN 113143881 B CN113143881 B CN 113143881B CN 202110265936 A CN202110265936 A CN 202110265936A CN 113143881 B CN113143881 B CN 113143881B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4816—Wall or shell material
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Abstract
The invention relates to the technical field of auxiliary materials in medicinal preparations, and provides a hollow capsule capable of being filled with a water-containing liquid medicinal preparation, which overcomes the defects of the prior art, is convenient to prepare, high in safety and capable of being filled with the water-containing liquid medicinal preparation, meets the requirements of special liquid medicaments, and promotes the development of medicinal dosage forms, and is prepared by the following method: s1, dissolving an enteric film-forming material A in a mixed solution B of an organic solvent and water to prepare a glue solution C with the mass part of 10-20%; and S2, performing a capsule forming process on the glue solution C to obtain the hollow capsule with the cap body and the locking ring as the double-locking ring. The invention is not only suitable for filling oily liquid medicament dosage forms, but also is especially suitable for developing water-containing liquid medicament molding, and has higher social use value and application prospect.
Description
Technical Field
The invention relates to the technical field of auxiliary materials in medicinal preparations, in particular to a hollow capsule capable of being filled with a water-containing liquid medicinal preparation.
Background
The hollow capsule has the effects of isolating peculiar smell of the medicine and being convenient to take due to attractive appearance, and is simple to fill the medicine, so that the hollow capsule is widely applied to the preparation of medicines, health-care products and the like.
At present, some domestic medicines need water to protect the curative effect of the medicines, and the curative effect of the medicines is greatly reduced or even ineffective after the water is lost. The existing empty capsules are mainly gelatin empty capsules which adopt animal-derived gelatin as a main raw material, cannot be used for containing water-containing liquid medicinal preparations, only can be filled with oily medicinal preparations, and the oily medicaments cannot contain water. To this end, a hollow capsule is provided which can be filled with an aqueous liquid pharmaceutical preparation.
Disclosure of Invention
Technical problem to be solved
Aiming at the defects of the prior art, the invention provides the empty capsule capable of being filled with the aqueous liquid medicinal preparation, which overcomes the defects of the prior art, is convenient to prepare and high in safety, can be filled with the aqueous liquid medicinal preparation, meets the requirements of all liquid (including oily and aqueous) special medicaments, and fills the development of the dosage form which cannot be filled with the aqueous liquid medicinal preparation.
(II) technical scheme
In order to achieve the purpose, the invention is realized by the following technical scheme:
an empty capsule fillable with an aqueous liquid pharmaceutical formulation, the empty capsule prepared by the process of:
s1, dissolving an enteric film-forming material A in a mixed solution B of an organic solvent and water to prepare a glue solution C with the mass part of 10-20%;
s2, performing a capsule forming process on the glue solution C to obtain a hollow capsule with a double-locking ring as a cap body and a locking ring;
the capsule forming process comprises the following specific steps:
s2-1, putting the enteric film forming material A and the mixed solution B into a sol tank under the conditions of normal temperature and normal pressure, and stirring until the enteric film forming material A and the mixed solution B are completely dissolved to prepare a glue solution C;
s2-2, filtering the glue solution C through a filter bag, and sequentially performing color matching, standing, sealing and natural deaeration;
s2-3, injecting the processed glue solution C into a glue plate, carrying out glue dipping molding in the glue plate by using a double-lock ring mold, wherein the temperature of the glue plate is 18-30 ℃, and then placing the glue plate in an oven to dry and mold a glue blank, wherein the drying temperature is 20-35 ℃ and the drying time is 30-60 minutes;
it can be understood that the solidification of the glue solution C on the double-lock-ring die in the glue dipping process is realized by the continuous volatilization of the organic solvent (acetone and/or ethanol) without high-temperature treatment
S2-4, taking the dried rubber blank, and carrying out demoulding, cutting, nesting, checking and packaging to obtain the hollow capsule.
Preferably, the enteric film-forming material A comprises hydroxypropyl methylcellulose phthalate, fiber vinegar processed ester, corn meal and hydroxypropyl methylcellulose acetate succinate.
Preferably, the mixed solution B comprises 70-80% of ethanol and 20-30% of water in parts by volume.
Preferably, the mixed solution B comprises 70-80% of acetone and 20-30% of water in parts by volume.
Preferably, the mixed solution B comprises 35-40% of acetone, 35-40% of ethanol and 20-30% of water in parts by volume.
Preferably, in the step S2-3, the glue dipping process is to dip glue for the first time by using a mold, the surface temperature of the mold is 50-60 ℃, and the thickness of the capsule cured and dried on the mold is measured after the glue solution is cured and dried on the mold, so that the capsule can be formed in one step or formed by dipping glue for multiple times until the required thickness is achieved.
(III) advantageous effects
The embodiment of the invention provides an empty capsule capable of being filled with a water-containing liquid medicinal preparation, which has the following beneficial effects:
1. the hollow capsule provided by the invention has strong acid resistance, is not brittle and has very low moisture; has good moisture resistance, and can be used for containing aqueous liquid medicinal preparation.
2. The preparation method of the hollow capsule provided by the invention has the advantages of high speed, no need of heating and low energy consumption; and because the heating is not needed, the gelling agent is not added, the influence of the gelling agent on the disintegration is avoided, the capsule is solidified and formed only by the volatilization of the organic solvent, the filling of oily pharmaceutical preparations is adapted, and the filling of special water-containing medicaments can be particularly suitable, and the water-containing liquid pharmaceutical preparations can be accommodated.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail with reference to the following embodiments. It should be understood that the embodiments described herein are merely illustrative of the present invention and are not intended to limit the present invention.
Example 1
An empty capsule fillable with an aqueous liquid pharmaceutical formulation, the empty capsule prepared by the process of:
s1, dissolving 1.0kg of hydroxypropyl methylcellulose phthalate in a mixed solvent B1 of 70% of acetone and 30% of water in parts by volume to prepare a glue solution C1 with the mass part of 20%;
s2, performing a capsule forming process on the glue solution C1 to obtain a hollow capsule with a double-locking ring as a cap body and a locking ring;
the capsule forming process comprises the following specific steps:
s2-1, dissolving 1.0kg of hydroxypropyl methylcellulose phthalate in a mixed solvent B1 of 70% acetone and 30% water in parts by volume in a sol tank under the conditions of normal temperature and normal pressure, and stirring until the hydroxypropyl methylcellulose phthalate is completely dissolved to prepare a glue solution C1;
s2-2, filtering the glue solution C1 by using a filter bag, and then sequentially performing color matching, standing, sealing and natural deaeration to prepare before glue dipping;
s2-3, injecting the treated glue solution C1 into a glue tray, carrying out glue dipping molding in the glue tray by using a double-lock-ring mold at the temperature of 18-30 ℃ and 50-60 ℃, and then placing the glue tray in an oven to dry and mold a glue blank at the temperature of 20-35 ℃ for 30-60 minutes;
s2-4, taking the dried rubber blank, and carrying out demoulding, cutting, nesting, checking and packaging to obtain the hollow capsule.
Example 2
An empty capsule fillable with an aqueous liquid pharmaceutical formulation, the empty capsule prepared by the process of:
s1, dissolving 1.0kg of hydroxypropyl methylcellulose phthalate in a mixed solvent B2 of 80% of acetone and 20% of water in parts by volume to prepare a glue solution C2 with the mass part of 10%;
s2, performing a capsule forming process on the glue solution C2 to obtain a hollow capsule with a double-locking ring as a cap body and a locking ring;
the capsule forming process comprises the following specific steps:
s2-1, dissolving 1.0kg of hydroxypropyl methylcellulose phthalate in a mixed solvent B2 of 80% acetone and 20% water in parts by volume in a sol tank under the conditions of normal temperature and normal pressure, and stirring until the hydroxypropyl methylcellulose phthalate is completely dissolved to prepare a glue solution C2;
s2-2, filtering the glue solution C2 through a filter bag, sequentially carrying out color matching, standing, sealing and natural defoaming, and preparing before glue dipping;
s2-3, injecting the processed glue solution C2 into a glue plate, carrying out glue dipping molding in the glue plate by using a double-lock ring mold, wherein the temperature of the glue plate is 18-30 ℃, the temperature of the double-lock ring mold is 50-60 ℃, and then placing the glue plate in an oven to dry and mold a glue blank, wherein the drying temperature is 20-35 ℃, and the drying time is 30-60 minutes;
and S2-4, taking the dried rubber blank, and carrying out demolding, cutting, nesting, inspecting and packaging to obtain the hollow capsule.
Example 3
An empty capsule fillable with an aqueous liquid pharmaceutical formulation, the empty capsule prepared by the process of:
s1, dissolving 1.0kg of hydroxypropyl methylcellulose phthalate in a mixed solvent B3 of 40% acetone, 40% ethanol and 20% water in parts by volume to prepare a glue solution C3 with the mass part of 10%;
s2, performing a capsule forming process on the glue solution C3 to obtain a hollow capsule with a double-locking ring as a cap body and a locking ring;
the capsule forming process comprises the following specific steps:
s2-1, dissolving 1.0kg of hydroxypropyl methylcellulose phthalate in a mixed solvent B3 of 40% acetone, 40% ethanol and 20% water in parts by volume in a sol tank under the conditions of normal temperature and normal pressure, and stirring until the hydroxypropyl methylcellulose phthalate is completely dissolved to prepare a glue solution C3;
s2-2, filtering the glue solution C3 through a filter bag, sequentially carrying out color matching, standing, sealing and natural defoaming, and preparing before glue dipping;
s2-3, injecting the processed glue solution C3 into a glue plate, carrying out glue dipping molding in the glue plate by using a double-lock ring mold, wherein the temperature of the glue plate is 18-30 ℃, the temperature of the double-lock ring mold is 50-60 ℃, and then placing the glue plate in an oven to dry and mold a glue blank, wherein the drying temperature is 20-35 ℃, and the drying time is 30-60 minutes;
and S2-4, taking the dried rubber blank, and carrying out demolding, cutting, nesting, inspecting and packaging to obtain the hollow capsule.
Example 4
An empty capsule fillable with an aqueous liquid pharmaceutical formulation, the empty capsule prepared by a method comprising:
s1, dissolving 1.0kg of hydroxypropyl methylcellulose phthalate in a mixed solvent B4 of 35% of acetone, 35% of ethanol and 30% of water in parts by volume to prepare a glue solution C4 with the mass part of 20%;
s2, performing a capsule forming process on the glue solution C4 to obtain a hollow capsule with a double-locking ring as a cap body;
the capsule forming process comprises the following specific steps:
s2-1, dissolving 1.0kg of hydroxypropyl methylcellulose phthalate in a mixed solvent B4 of 80% acetone and 20% water in parts by volume in a sol tank under the conditions of normal temperature and normal pressure, and stirring until the hydroxypropyl methylcellulose phthalate is completely dissolved to prepare a glue solution C4;
s2-2, filtering the glue solution C4 by using a filter bag, sequentially carrying out color matching, standing, sealing and natural defoaming, and preparing before glue dipping;
s2-3, injecting the processed glue solution C4 into a glue plate, carrying out glue dipping molding in the glue plate by using a double-lock ring mold, wherein the temperature of the glue plate is 18-30 ℃, the temperature of the double-lock ring mold is 50-60 ℃, and then placing the glue plate in an oven to dry and mold a glue blank, wherein the drying temperature is 20-35 ℃, and the drying time is 30-60 minutes;
s2-4, taking the dried rubber blank, and carrying out demoulding, cutting, nesting, checking and packaging to obtain the hollow capsule.
The hollow capsules prepared in the embodiments 1 to 4 are compared with five hollow capsules of the Chinese pharmacopoeia standard in the prior art for performance test;
the disintegration time of the hollow capsule is tested by a method for checking the disintegration time limit of the hollow capsule in 2020 edition of Chinese pharmacopoeia. Disintegration time limit inspection method: taking hydroxypropyl methylcellulose phthalate, filling 6 produced hollow capsules with talcum powder, checking in 9ml hydrochloric acid and water to 1000ml gastric acid according to the method under the item of disintegration time limit inspection (0921 in 2020 version of Chinese pharmacopoeia), and measuring the acid resistance time of the capsules.
The drying weight loss of the hydroxypropyl methylcellulose phthalate hollow capsule is detected by a drying weight loss inspection method of hollow capsules in 2020 edition of Chinese pharmacopoeia. The detection method comprises the following steps: taking 1.0g of the hollow capsule, separating the cap and the body of the capsule, drying for 6 hours at 105 ℃, weighing, calculating the weight loss due to water loss, and taking the percentage of water loss as the loss on drying.
The friability of the hydroxypropyl methylcellulose phthalate hollow capsules is detected by a method for inspecting the friability of the hollow capsules in the 2020 edition of Chinese pharmacopoeia. Friability detection method: taking 50 hollow capsules, placing the capsules in a watch glass, placing the capsules in a dryer filled with a saturated solution of magnesium nitrate, keeping the temperature at 25 +/-1 ℃ for 24 hours, taking out the capsules, immediately placing the capsules one by one into a glass tube (with the inner diameter of 24mm and the length of 200 mm) which is vertically arranged on a wood board (with the thickness of 2 cm), freely dropping cylindrical weights (made of polytetrafluoroethylene, the diameter of 22mm and the weight of 20g +/-0.lg) from the opening of the glass tube, and observing the number of broken capsules.
The water is filled into the hollow capsule, the hollow capsule is sealed and packaged after being locked, and the hollow capsule is stored and observed at normal temperature to verify whether the capsule can contain water or not.
I.e., the test comparisons included acid resistance time, loss on drying, friability, and water holding time, the results are shown in table 1:
TABLE 1
As can be seen from table 1, the hollow capsules provided by the present invention are strong in acid resistance, not brittle, and very low in moisture, and moisture-proof and can hold aqueous liquid pharmaceutical preparations; the preparation method of the capsule is high in speed, heating is not needed, and energy consumption is low; and because the heating is not carried out, the gelling agent is not added, the influence of the gelling agent on the disintegration is avoided, the capsule is solidified and formed only by the volatilization of the organic solvent, and the capsule is suitable for filling special medicines with high water content and can be filled with water-containing liquid medicine preparations.
The embodiments of the present invention are disclosed as the preferred embodiments, but not limited thereto, and those skilled in the art can easily understand the spirit of the present invention and make various extensions and changes without departing from the spirit of the present invention.
Claims (1)
1. An empty capsule fillable with an aqueous liquid pharmaceutical formulation, the empty capsule being prepared by a process comprising:
s1, dissolving an enteric film-forming material A in a mixed solution B of an organic solvent and water to prepare a glue solution C with the mass part of 10-20%;
wherein the enteric film-forming material is hydroxypropyl methylcellulose phthalate;
according to the volume parts, the mixed solution B is 70-80% of acetone and 20-30% of water, or 35-40% of acetone, 35-40% of ethanol and 20-30% of water;
s2, performing a capsule forming process on the glue solution C to obtain a hollow capsule with a double-locking ring as a cap body;
the capsule forming process comprises the following specific steps:
s2-1, putting the enteric film-forming material A and the mixed solution B into a sol tank under the conditions of normal temperature and normal pressure, and stirring until the enteric film-forming material A and the mixed solution B are completely dissolved to prepare a glue solution C;
s2-2, filtering the glue solution C through a filter bag, and sequentially performing color matching, standing, sealing and natural deaeration;
s2-3, injecting the treated glue solution C into a glue tray, and carrying out glue dipping molding in the glue tray by using a double-lock-ring mold, wherein the temperature of the glue tray is 18-30 ℃, and then placing the glue tray in an oven to dry and mold a glue blank, wherein the drying temperature is 20-35 ℃ and the drying time is 30-60 minutes;
s2-4, taking the dried rubber blank, and performing demoulding, cutting, sleeving, checking and packaging to obtain an empty capsule;
in the step S2-3, the glue dipping process is to dip glue for the first time by using a mould, the surface temperature of the mould is 50-60 ℃, the thickness of the cured and dried capsule on the mould is measured after the glue solution is cured and dried on the mould, and the capsule can be formed in one step or formed by dipping glue for multiple times until the required thickness is met.
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| CN202110265936.7A CN113143881B (en) | 2021-03-11 | 2021-03-11 | Empty capsule capable of being filled with aqueous liquid medicinal preparation |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202110265936.7A CN113143881B (en) | 2021-03-11 | 2021-03-11 | Empty capsule capable of being filled with aqueous liquid medicinal preparation |
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| CN113143881B true CN113143881B (en) | 2022-11-22 |
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Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2006016372A (en) * | 2004-07-05 | 2006-01-19 | Shionogi Qualicaps Co Ltd | Enteric hard capsule formulation |
| CN102526750A (en) * | 2012-01-06 | 2012-07-04 | 安徽黄山胶囊股份有限公司 | Plant colonic-coated hollow capsule |
| CN107296801A (en) * | 2017-08-09 | 2017-10-27 | 安徽黄山胶囊股份有限公司 | A kind of hydroxypropyl methyl cellulose plant hollow capsule |
| CN110115685A (en) * | 2019-06-19 | 2019-08-13 | 江苏力凡胶囊有限公司 | A kind of empty hard capsule of the filling liquid with closing component structure |
| CN110467681A (en) * | 2018-05-11 | 2019-11-19 | 信越化学工业株式会社 | Hypromellose Phthalate and preparation method thereof |
-
2021
- 2021-03-11 CN CN202110265936.7A patent/CN113143881B/en active Active
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2006016372A (en) * | 2004-07-05 | 2006-01-19 | Shionogi Qualicaps Co Ltd | Enteric hard capsule formulation |
| CN102526750A (en) * | 2012-01-06 | 2012-07-04 | 安徽黄山胶囊股份有限公司 | Plant colonic-coated hollow capsule |
| CN107296801A (en) * | 2017-08-09 | 2017-10-27 | 安徽黄山胶囊股份有限公司 | A kind of hydroxypropyl methyl cellulose plant hollow capsule |
| CN110467681A (en) * | 2018-05-11 | 2019-11-19 | 信越化学工业株式会社 | Hypromellose Phthalate and preparation method thereof |
| CN110115685A (en) * | 2019-06-19 | 2019-08-13 | 江苏力凡胶囊有限公司 | A kind of empty hard capsule of the filling liquid with closing component structure |
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Denomination of invention: A hollow capsule capable of filling aqueous liquid pharmaceutical formulations Effective date of registration: 20230830 Granted publication date: 20221122 Pledgee: Agricultural Bank of China Limited Jingde County Branch Pledgor: ANHUI HUANGSHAN CAPSULE Co.,Ltd. Registration number: Y2023980054456 |